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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ LUER-LOK¿ SYRINGE HYPODERMIC SYRINGE

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ LUER-LOK¿ SYRINGE HYPODERMIC SYRINGE Back to Search Results
Catalog Number 300629
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported with the use of the bd plastipak¿ luer-lok¿ syringe there was an issue with difficult plunger movement. It was stated ¿the customer is working on the pharmacy (cytostatic department) where they regularly draw up a lot of medicine in our bd plastipak. They complain that the stamp is very tight on all the mentioned syringes sizes (3, 5, 10, 20, 30 ml). They are aware about pressing the syringe plunger all the way down to make the syringe plunger slide more easily before use, but they still think it is very hard to work with. ¿ there was no report of injury or further medical intervention.
 
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Brand NameBD PLASTIPAK¿ LUER-LOK¿ SYRINGE
Type of DeviceHYPODERMIC SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7588158
MDR Text Key111161339
Report Number3003152976-2018-00238
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300629
Device Lot Number1802278
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/11/2018 Patient Sequence Number: 1
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